FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COACUTE HEPARIN
K Number: K952514
·
Decision Nov 20, 1995
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
45
Applicant Total
4
Review Days
173
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Basic Information
- Device Name
- COACUTE HEPARIN
- K Number
- K952514
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7525
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chromogenix AB
- Date Received
- May 31, 1995
- Decision Date
- November 20, 1995
- Product Code
- KFF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KFF | Assay, Heparin | FDA class 2 | Hematology |
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